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The Role
Executes global CMC regulatory strategies for post-approval pharmaceutical changes, including product change assessments, health authority responses, regulatory submissions, dossier updates, and technical justifications. Coordinates cross-functional reviews, document sign-off, query and commitment management, risk escalation, and regulatory system maintenance. The role requires applying international regulatory guidelines and managing multiple projects under team-lead guidance.
Summary Generated by Built In
JOB SUMMARY
Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changesglobally in collaboration with the CMC GRS.
Responsible for development and execution of regulatory strategiesincluding response to HA queries.
Manages day-to-day regulatory activities associated with assigned PCFs within agreed upontimelines.
Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure thedeliverables.
Works in a structured environment with supervision from Team Lead.
Liaise with Pfizer Global Supply and other support functions as needed.
Use of regulatory systems and management of CMC documentation and information in support ofthe CMC GRS.
JOB RESPONSIBILITIES
Functions as CMC author/strategist for development and execution of regulatory strategies for theassigned changes which include minor and/or moderate post approval changes/projects/products
Responsible for end to end PCF assessment
Authors and compiles response to HA queries within agency timelines
Projects involving complex CMC changes shall be assigned through mentoring as a part of careerdevelopment, if identified
Reviews proposed changes for completeness and accuracy and development of initial globalregulatory strategy while considering registered content and seeks endorsement by the CMC GRS.
Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMCsubmission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMCGRS as appropriate and within agreed timelines.
Major and Emerging Market focused
Reviews technical/supportive information for submission to support change
Reviews and applies pertinent global regulatory guidelines
Develops technical justification of change for agency submission
Updates M3 dossier
Coordinates M3.2.R Ancillary documents
Escalates delays in timelines and contributes to the Identifion and mitigation of risks with the support of TL/designee; flags identified risks to the CMC GRS and/or appropriate leadership
Makes decisions to resolve minor problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership
Flags identified risks to the CMC GRS and/or appropriate leadership
Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges.
Coordinates internal document review and sign off.
Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
Supports Query and/or commitment management in collaboration with CMC GRS.
Maintains conformance systems maintenance in support of the CMC GRS.
QUALIFICATIONS / SKILLS
Minimum - Postgraduate in Pharmacy or Science
Minimum 3 to 7 years of CMC experience within a regulatory function with Knowledge of EU/US and international regulatory practices, policies.
Proficiency in Microsoft windows, Trackwise, Navigation or similar submission management tools document management systems, publishing tools and operating knowledge of databases.
Good verbal and written communication skills.
Motivated, good interpersonal skills, organized, hardworking, agile, adaptable to change and able to meet timelines.
Team player and ability to work in a highly matrixed environment.
Customer focus and attention to detail and accuracy is required.
Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills.
Willingness to work flexible hours.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Regulatory Affairs
Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changesglobally in collaboration with the CMC GRS.
Responsible for development and execution of regulatory strategiesincluding response to HA queries.
Manages day-to-day regulatory activities associated with assigned PCFs within agreed upontimelines.
Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure thedeliverables.
Works in a structured environment with supervision from Team Lead.
Liaise with Pfizer Global Supply and other support functions as needed.
Use of regulatory systems and management of CMC documentation and information in support ofthe CMC GRS.
JOB RESPONSIBILITIES
Functions as CMC author/strategist for development and execution of regulatory strategies for theassigned changes which include minor and/or moderate post approval changes/projects/products
Responsible for end to end PCF assessment
Authors and compiles response to HA queries within agency timelines
Projects involving complex CMC changes shall be assigned through mentoring as a part of careerdevelopment, if identified
Reviews proposed changes for completeness and accuracy and development of initial globalregulatory strategy while considering registered content and seeks endorsement by the CMC GRS.
Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMCsubmission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMCGRS as appropriate and within agreed timelines.
Major and Emerging Market focused
Reviews technical/supportive information for submission to support change
Reviews and applies pertinent global regulatory guidelines
Develops technical justification of change for agency submission
Updates M3 dossier
Coordinates M3.2.R Ancillary documents
Escalates delays in timelines and contributes to the Identifion and mitigation of risks with the support of TL/designee; flags identified risks to the CMC GRS and/or appropriate leadership
Makes decisions to resolve minor problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership
Flags identified risks to the CMC GRS and/or appropriate leadership
Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges.
Coordinates internal document review and sign off.
Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
Supports Query and/or commitment management in collaboration with CMC GRS.
Maintains conformance systems maintenance in support of the CMC GRS.
QUALIFICATIONS / SKILLS
Minimum - Postgraduate in Pharmacy or Science
Minimum 3 to 7 years of CMC experience within a regulatory function with Knowledge of EU/US and international regulatory practices, policies.
Proficiency in Microsoft windows, Trackwise, Navigation or similar submission management tools document management systems, publishing tools and operating knowledge of databases.
Good verbal and written communication skills.
Motivated, good interpersonal skills, organized, hardworking, agile, adaptable to change and able to meet timelines.
Team player and ability to work in a highly matrixed environment.
Customer focus and attention to detail and accuracy is required.
Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills.
Willingness to work flexible hours.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Regulatory Affairs
Skills Required
- Postgraduate degree in Pharmacy or Science
- 3 to 7 years of CMC experience within a regulatory function
- Knowledge of EU, US, and international regulatory practices and policies
- Proficiency with Microsoft Windows
- Experience with TrackWise, Navigation, or similar submission management tools
- Experience with document management systems and publishing tools
- Operating knowledge of databases
- Good verbal and written communication skills
- Ability to work in a highly matrixed environment
- Ability to prioritize and manage multiple projects with guidance
- Strong organization, attention to detail, and accuracy
- Willingness to work flexible hours
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, and robust mental‑health benefits, with eligible Pfizer medications available at no cost in U.S. plans. Family‑building support and transgender‑inclusive care are explicitly included, alongside wellbeing resources such as a reimbursement wallet and telehealth options.
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Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional Retirement Savings Contribution, complemented by company‑subsidized life, short‑term disability, and long‑term disability insurance. Materials also reference subsidized retiree medical coverage for eligible groups.
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Leave & Time Off Breadth — Paid vacation, holidays, personal days, and paid parental and caregiver leave are consistently highlighted in current U.S. summaries and job postings. Options like buying extra vacation days and transition‑back support strengthen the time‑off offering.
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
Hudson Yards
Provincia de Buenos Aires
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Collegeville, PA
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Madrid, ES
Mumbai, Maharashtra
Rochester, MI
San Diego, CA
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Tampa, FL
Center for Digital Innovation
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